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Impax shares rise on Parkinson's drug data

Share value of Impax Laboratories climbed 16 per cent after the company announced positive results from a phase III study of an investigational therapy for Parkinson's disease

Share value of Impax Laboratories climbed 16 per cent on Tuesday after the company hosted a conference call discussing positive results from a phase III study of an investigational therapy for Parkinson's disease that it out-licensed to GlaxoSmithKline (GSK) late last year.

Impax's shares, which are traded on the NASDAQ exchange, ended the day up $3.45 at $25.52.

The company said that top-line results showed its extended-release carbidopa-levodopa combination, known as IPX066, was superior to immediate-release carbidopa-levodopa (IR CD-LD), the current standard of treatment, in advanced PD patients experiencing motor fluctuations.

Called ADVANCE-PD, the study demonstrated that IPX066 "produced significantly improved control of motor symptoms as compared to immediate-release carbidopa-levodopa in multiple clinical measures in subjects with advanced PD."

This included the percentage of "off-time" – the time when medication has worn off and symptoms return -- during waking hours, which was the primary endpoint.

IPX066 produced a 37 per cent improvement in off-time from baseline, while the immediate-release product resulted in a 17 per cent improvement from baseline. The study enrolled 471 subjects on a stable regimen of IR CD-LD who were first entered into a dose-adjustment phase of their IR CD-LD, followed by a conversion to IPX066 and then randomisation to either IPX066 or IR CD-LD.

Impax said it has now completed the phase III studies recommended by the US Food and Drug Administration (FDA) for the new drug application and is aiming to file the application by the fourth quarter of 2011. The company said it plans to present the full results of the ADVANCE-PD study at an upcoming scientific meeting.

Impax is also conducting the ASCEND-PD comparative study of IPX066 and carbidopa-levodopa and entacapone, which is currently enrolling subjects, as well as an open-label extension study for the ADVANCE-PD subjects.

Under a December 2010 development and commercialisation agreement, GSK received an exclusive licence to sell IPX066 everywhere in the world except the US and Taiwan.

16th March 2011

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